Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tg Medical Sdn. Bhd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
299 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for U | Tg Medical Sdn. Bhd. | 2017-08-21 | 112 | 0 |
| K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | Tg Medical Sdn. Bhd. | 2012-09-11 | 299 | 0 |
| K993562 | POWDER FREE LATEX STERILE SURGICAL GLOVES | Tg Medical Sdn. Bhd. | 1999-12-29 | 69 | 0 |
| K992841 | TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES | Tg Medical Sdn. Bhd. | 1999-10-29 | 66 | 0 |
| K992360 | TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES | Tg Medical Sdn. Bhd. | 1999-10-12 | 89 | 0 |
| K992219 | POWDERED LATEX STERILE SURGICAL GLOVES | Tg Medical Sdn. Bhd. | 1999-07-30 | 29 | 0 |
| K990668 | POWDER FREE BLUE NITRILE GLOVE | Tg Medical Sdn. Bhd. | 1999-06-03 | 93 | 0 |
| K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABEL | Tg Medical Sdn. Bhd. | 1998-10-15 | 62 | 1 |
| K941900 | POWDERED LATEX EXAM GLOVES | Tg Medical Sdn. Bhd. | 1994-06-21 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda